FDA.reportPublic FDA data

Chamosyn

Product NDC
51028-003
Requested package NDC
51028-003-00
11-digit product format
510280003
Labeler code
51028
Product ID
51028-003_34a97f44-835c-ebb7-e063-6294a90a5b67
Type
HUMAN OTC DRUG
Nonproprietary name
Barrier Cream
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Links Medical Products
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-01
Substance
MENTHOL; ZINC OXIDE
Active strength
4.5; 200 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Chamosyn
Brand name suffix
Paraben Free
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4.5 mg/g
ZINC OXIDE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884804Internal RxNorm lookup
1998442Internal RxNorm lookup
2730301Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9dfb2d7-4684-4525-994e-1e0ff90413d9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
51028-003-002023-10-16Chamosyn with Manuka Honey
51028-003-012023-10-16Chamosyn with Manuka Honey
51028-003-002021-07-23Chamosyn with Manuka Honey
51028-003-012021-07-23Chamosyn with Manuka Honey

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51028-003-00ChamosynParaben Free5 g in 1 PACKETOINTMENT58
51028-003-00ChamosynParaben Free144 in 1 BOXOINTMENT1448
51028-003-01ChamosynParaben Free113 g in 1 TUBEOINTMENT1138

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51028-003CHAMOSYN PARABEN FREE (BARRIER CREAM) OINTMENT CHAMOSYN (BARRIER CREAM) OINTMENT [LINKS MEDICAL PRODUCTS]7Current NDC, Legacy NDC, 3 package rows20241215_f9dfb2d7-4684-4525-994e-1e0ff90413d9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flarestop Hemorrhoid LidocaineLIDOCAINEChelsea Pharmacceuticals LLCb8a589f7-7131-4807-9bcb-84af3078e2582026-09-10WarningsExact identifier
application number: M015
BCBCYC Numbing CreamLIDOCAINE 5% NUMBING CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab36566-ba2f-06ef-e063-6394a90a71b52026-09-10WarningsExact identifier
application number: M015
5% Lidocaine 10g5% LIDOCAINEChongqing Mandongzi Technology Co., Ltd5b10530f-47cd-c4bd-e063-6294a90aaa0a2026-09-09WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
application number: M015
Flushable Hemorrhoidal Medicated Wipes Maximum StrengthWITCH HAZELAmazon.com Services LLC41d756f3-e523-ed14-e063-6394a90ab8172026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch HazelHEMORRHOIDAL WIPES WITH WITCH HAZELBetter Living Brands LLCadf26111-70ba-596c-e053-2995a90ac6f12026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
up and up medicated wipes manixim strengthGENTLE HEMORRHOIDAL CARETarget Corporation271eab2b-ed13-39f1-e054-00144ff88e882026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
KROGER MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOEWITCH HAZEL CLOTHThe Kroger Co.48c1598d-6667-446f-ac90-10ab945d06172026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazelWITCH HAZELOld East Main Co.2055289d-962e-46a9-b371-b5bb93dd46b42026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Equate Hemorrhoidal Medicated WipesWITCH HAZELWalmart Inc.8d57f054-77dc-4205-85f1-b65dcfde677b2026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Lidocaine CreamLIDOCAINEInvaDerm Corporation5a7273d1-1dbc-420e-e063-6294a90a86292026-09-01WarningsExact identifier
application number: M015
Lidocaine PhenylephrineLIDOCAINE PHENYLEPHRINEYYBA CORP5a72a190-2129-411e-e063-6394a90a08c22026-09-01WarningsExact identifier
application number: M015
INICEI 5% LIDOCAINE Numbing Cream5% LIDOCAINE NUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5a65842f-27a1-268b-e063-6294a90a60542026-08-31WarningsExact identifier
application number: M015
AnievaLCLIDOCAINEBlackstone Products, LLCddaba14c-10de-44e2-ae13-9217e20cb48e2026-08-29WarningsExact identifier
application number: M015
Norms Hemorrhoid WipesWITCH HAZELTotally Normal Company5a1af50b-8d00-f589-e063-6394a90af86c2026-08-28WarningsExact identifier
application number: M015
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.59f0fa16-5eb0-e6bb-e063-6294a90aacf52026-08-26WarningsExact identifier
application number: M015
Dude Hemorrhoidal WipesWITCH HAZELDude Productsfdf408ef-9392-a812-e053-6394a90a00172026-08-25WarningsExact identifier
application number: M015
Norms Medicated WipesWITCH HAZELTotally Normal Company3a78e109-3f7c-fb19-e063-6394a90ae78e2026-08-22WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.599b425a-0e96-76df-e063-6394a90a48ff2026-08-21WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2730301Chamosyn 0.45 % / 20 % Topical OintmentPSNf9dfb2d7-4684-4525-994e-1e0ff90413d98
1998442menthol 0.1 % / zinc oxide 20 % Topical OintmentPSNf9dfb2d7-4684-4525-994e-1e0ff90413d98
884804menthol 0.45 % / zinc oxide 20 % Topical OintmentPSNf9dfb2d7-4684-4525-994e-1e0ff90413d98
2730301menthol 0.0045 MG/MG / zinc oxide 0.2 MG/MG Topical Ointment [Chamosyn]SBDf9dfb2d7-4684-4525-994e-1e0ff90413d98
1998442menthol 0.001 MG/MG / zinc oxide 0.2 MG/MG Topical OintmentSCDf9dfb2d7-4684-4525-994e-1e0ff90413d98
884804menthol 0.0045 MG/MG / zinc oxide 0.2 MG/MG Topical OintmentSCDf9dfb2d7-4684-4525-994e-1e0ff90413d98
2730301Chamosyn (menthol 0.45 % / zinc oxide 20 % ) Topical OintmentSYf9dfb2d7-4684-4525-994e-1e0ff90413d98
1998442Menthol 0.001 MG/MG / ZNO 0.2 MG/MG Topical OintmentSYf9dfb2d7-4684-4525-994e-1e0ff90413d98
884804Menthol 0.0045 MG/MG / ZNO 0.2 MG/MG Topical OintmentSYf9dfb2d7-4684-4525-994e-1e0ff90413d98
2730301menthol 0.0045 MG/MG / ZNO 0.2 MG/MG Topical Ointment [Chamosyn]SYf9dfb2d7-4684-4525-994e-1e0ff90413d98
1998442menthol 0.1 % / zinc oxide 20 % Topical OintmentSYf9dfb2d7-4684-4525-994e-1e0ff90413d98
884804menthol 0.45 % / zinc oxide 20 % Topical OintmentSYf9dfb2d7-4684-4525-994e-1e0ff90413d98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51028-003-0051028000300144 PACKET in 1 BOX (51028-003-00) / 5 g in 1 PACKET144 packet2016-01-010000-00-00NoNoCurrent